It has been nearly 25 years since the Food and Drug Administration first issued guidance related to racial, ethnic, age, and gender populations underrepresented in clinical trials (see “Timeline: Related prior FDA guidance”). Yet it and other agency guidance and clear documentation of unequal representation have yielded little progress in improving clinical trial diversity.
The FDA’s latest draft guidance on diversity among clinical trial participants, published in April 2022, along with other efforts by the agency and other governmental entities to improve representation in clinical trials, is a welcome step forward.